Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

FDA DECLINES TO REVIEW CARDIOME'S CARDIOVASCULAR DRUG NDA

The U.S. FDA has declined to
review Canada-based Cardiome Pharma's new drug application (NDA) for an investigational
cardiovascular drug, the company announced.

In a recent press release, Cardiome said its development partner, Astellas
Pharma, has received a "refusal to file" letter from the FDA for RSDD1235
(iv), designed for acute conversion of atrial fibrillation. The company said
the FDA's reasons included "inconsistencies and omissions in the databases
submitted with the NDA" but added that this action is not an indication
of the potential approvability of the drug in the future

Cardiome CEO Bob Reider said in a statement that the company is reviewing the
NDA with the intent to resolve the FDA's concerns.

The FDA's decision not only delays the marketing of the drug but also puts
off a $10 million milestone payment, under the agreement with Astellas, due
to Cardiome on acceptance of the NDA. As of Dec. 31, 2005, the company reported
having approximately $8.4 million cash on hand.